[LINK] 23andme now approved by the FDA to deliver health reports
http://blog.23andme.com/23andme-and-you/a-new-23andme-experience/
Looks like they were finally able to work out something with the FDA, and are back up and running. On the one hand, I’m very excited about the return of personalized genetic testing, but on the other hand I’m disappointed that their price doubled to $199. I was going to get kits for my 4-member family for Christmas, but that won’t be feasible now.
Another interesting release from 23andme that came out at the same time is their [transparency report](https://www.23andme.com/transparency-report/), which shows how many requests from law enforcement they have gotten for customer DNA access, and what percentage they have gone through with.
As far as I can tell, none of the “health” results are about the patient’s health, only carrier status relevant to potential children. I imagine that is why the FDA is quicker to approve these tests than others, because there is not much the patient can do to act on it. (In theory the test could diagnose the same diseases, but I think they are all severe enough that the patient is expected to already know. Maybe they would be diagnostic for children.)
Except that they do predict lactose intolerance. That is in the “wellness” category, which I suspect are things that the FDA said it didn’t care about.
That’s my understanding as well. New customers can’t get the old health reports despite this tiny opening:
https://reason.com/blog/2015/10/21/fda-takes-one-regulatory-shackle-off-23a
Although earlier users (like myself) still have access to their health reports, I suspect 23andMe isn’t putting the same effort into them since they could no longer market them and give them to new customers.
The author responds in comments:
I use the Promethease report service. It’s probably better than what 23andMe is giving, though I expect in a free world 23andMe could do much better with all the genomes available and a customer base interested in sharing information and getting diagnosed.
Not yet, but 23andMe is still working on getting more tests approved. It’ll take some time, but at least they’re making progress, and the FDA isn’t totally shutting them out.
If the FDA took two years to make up standards for things that people have been doing without doctor involvement for decades, how long will it take for them to make up standards for 23andMe to be an over-the-counter competitor to Myriad? for 23andMe to do completely new things? a decade? five?
“I’m disappointed that their price doubled to $199.”
Me too. I got mine in 2010 when it was on sale for $99 on DNA day. I don’t know when the price went to $99 as a regular price, but it seems like a long time, and that was back when you got the health reports.
My version did 600k snps, then they went up to 1mil snp, and now they’re back down to 610k snps.
I’m disappointed that they haven’t expanded SNP coverage too. One of the benefits was supposed to be retesting with new versions without having to do the spittle mailer again—they’d just take more from the original sample. That first sample was supposed to be just the beginning of an ever expanding test.
They’ve really been stymied by the FDA. By killing the health reports for new customers, the FDA has really killed the potential market. We’re from the government, and we’re here to help!
That’s rather disappointing.
And that TRUSTe thing doesn’t seem very trust-able. Why would anyone use this?
Hm, can you elaborate on your disappointment? The report I’m seeing says that they’ve received 5 requests and filled 0. I don’t feel like I could ask for much better.